APX-PANTOPRAZOLE

What it is

APX-PANTOPRAZOLE contains pantoprazole (as sodium sesquihydrate) 20 mg or 40 mg as the active ingredient in enteric-coated tablets. Pantoprazole is a proton pump inhibitor that inhibits specifically and dose-proportionately H+/K+-ATPase, the enzyme responsible for gastric acid secretion in the parietal cells of the stomach.

Approved indications

— Symptomatic improvement and healing of duodenal ulcer — Symptomatic improvement and healing of gastric ulcer — Treatment of symptomatic gastro-oesophageal reflux disease (GORD): heartburn and other symptoms with GORD — Symptomatic improvement and healing of reflux oesophagitis — Symptomatic improvement and healing of gastrointestinal lesions refractory to H2 blockers — Symptomatic improvement and healing of Zollinger-Ellison Syndrome — Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis — Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment

Dosing overview

APX-PANTOPRAZOLE tablets are intended for oral administration and should not be chewed or crushed but swallowed whole with a little water.

Key safety warnings

Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile infection, and treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile. Pantoprazole may reduce the absorption of cyanocobalamin (vitamin B12) due to hypochlorhydria or achlorhydria; this should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy and in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment if respective clinical symptoms are observed. Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis have been reported in association with the use of proton pump inhibitors; discontinue pantoprazole at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity. Proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; the risk of fracture was increased in patients who received high-doses and long-term proton pump inhibitor therapy (a year or longer). Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including pantoprazole, may occur at any point during therapy and is generally associated with an idiopathic hypersensitivity reaction; discontinue pantoprazole if acute interstitial nephritis develops. Hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors for at least three months; serious consequences of hypomagnesaemia include tetany, arrhythmia, and seizure.

Contraindications

APX-PANTOPRAZOLE is contraindicated in patients with known hypersensitivity to pantoprazole, substituted benzimidazoles or any other components of the formulation, or in cases of cirrhosis or severe liver disease. Pantoprazole should not be co-administered with HIV protease inhibitors, such as atazanavir or nelfinavir.

Regulatory history

APX-PANTOPRAZOLE 20 mg and 40 mg enteric-coated tablet formulations were first listed on the Australian Register of Therapeutic Goods on 15 October 2013.